U.S. DEPARTMENT OF HEALTH AND HUMAN
SERVICES SUBCONTRACT
This Subcontract is made and entered into as of _______________________ by and between
Baylor College of Medicine located in Houston, Texas, hereinafter referred to as Baylor, and The
University of Texas Health Science Center at Houston located in Houston, Texas hereinafter
referred to as Subcontractor.
WITNESSETH
WHEREAS, Baylor has been awarded Grant Number 5 Uo1 AI27551-08 by the U.S.
Department of Health and Human Services (DHHS) for the project titled “Pediatric AIDS
Clinical Trials Program.”
WHEREAS, this grant provides funds for Subcontractor participation,
WHEREAS, Subcontractor processes the facilities, personnel and/or professional proficiency
requisite to the conduct of the work contemplated by this subcontract,
AND WHEREAS, it is in the best interest of Baylor to obtain assistance of Subcontractor in the
performance of the work required by the aforesaid grant.
Baylor and Subcontractor mutually agree as follows:
1. Description of Work
Subcontractor, as an independent contractor, not as an agent of the Government nor of
Baylor, shall furnish all necessary labor (including salary and fringe benefits), facilities
and equipment and shall exert its best efforts in carrying out the specific objectives set
out in the application for Grant 5 U01 AI27551-08 and summarized in “Exhibit A”.
2. Period of Performance
Performance of this Subcontract shall begin on ________________________and shall
not extend beyond the estimated completion date of _________________ unless the
period is extended by amendment of the Subcontract. Subcontractor will undertake to
complete the work indicated in “Exhibit A” during the contract period.
3. Compensation
a. Maximum Actual Cost
The actual cost to Baylor, including all direct and indirect costs, for the
performance of this work shall not exceed the estimated cost of $__________.
Subcontract agrees to use its best efforts to perform all work and all obligations
under this Subcontract within the estimated cost and the period of time set forth in
paragraph 2.
b. Indirect Costs
Indirect cost for this Subcontract shall be reimbursed at the rate of 19.0% MTDC
which you hereby represent is the negotiated indirect cost rate for your institution
which has been approved by your cognizant audit agency. These are maximum
rates.
c. Approved Budget
The approved budget is attached as “Exhibit B”.
d. Cost Determination
The allowability of costs shall be determined in accordance with the Public Health
Service Grants Policy Statement, DHHS Publication No. (OASH) 94-50,000
(Rev.) April 1, 1994; except that costs for Subcontractor’s independent research
and development shall not be allowable.
e. Prior Authorization of Certain Direct Costs
Subcontractor can use its Institutional Prior Approval System where applicable
provided that a copy of the approval is forwarded to Baylor. If subcontractor does
not have an Institutional Prior Approval System, then all requests for any
deviations from the approved budget should be sent to Baylor for review and
approval.
f. Foreign Travel
Requests for foreign travel must be submitted at least six weeks in advance, and
shall contain the following: (a) meeting(s) and place(s) to be visited, with costs
and dates; (b) name(s) and title(s) of personnel to travel and their functions in the
project; (c) purposes to be served by the travel; (d) how travel of personnel will
benefit and contribute to accomplishing the project, or will otherwise justify the
expenditures of funds; (e) how such advantages justify the costs for travel and
absence from the project of more than one person if such are suggested; and (f)
what additional functions may be performed by the traveler(s) to accomplish other
purposes of the project and thus further benefit the project.
4. Project Director
All work under this Subcontract shall be performed under the general guidance and
technical direction of the Project Director for Baylor, William T. Shearer, M.D. Such
guidance and direction shall not, however, effect any change in the cost structure of this
Subcontract, increase its estimated cost, or extend the period of performance. Such
changes shall be made only by Baylor in writing.
5. Publicity and Publications
Subcontractor shall include in any publications resulting from work performed under this
Subcontract an acknowledgment substantially as follows: The work upon which this
publication is based was performed pursuant to Grant No. 5 U01 AI27551-08 from the
U.S. Department of Health and Human Services. All publications will be provided to the
Project Director or his assignee at least sixty (60) days but no longer than ninety (90)
days prior to submission for publication. All publicity regarding this Subcontract will be
coordinated with the Project Director or his assignee.
6. Billing Instructions
Subcontractor shall submit monthly invoices, within thirty (30) calendar days following
the end of the month, to Baylor for reimbursement of expenses incurred in performance
of the project. Invoices should provide actual expenses grouped by category and shall
reference Baylor College of Medicine Purchase Order Number
_____________________________. Invoices should be submitted to the following
contact person:
Peter J. Marabella, Jr.
Director of Grants and Contracts
Office of Grants and Contracts
Baylor College of Medicine
One Baylor Plaza
Houston, Texas 77030-3498
Both parties agree that Baylor may withhold payment of any expenditure that appears
questionable, or for which additional information or support is required. Baylor agrees to
notify Subcontractor promptly of the item(s) being withheld from payment and the
reasons therefore. Subcontractor agrees to furnish Baylor such information as may be
required to satisfy reimbursement of the item(s) in questions. Subcontractor agrees to be
solely responsible, and holds Baylor harmless, for any expenditures made by it and
disallowed by DHHS, and agrees to make restitution to Baylor of funds so disallowed. In
the event of disputed items, Baylor shall obtain DHHS’s decision and said decision shall
prevail.
7. Key Personnel
The key personnel cited below are considered to be essential to the work being performed
hereunder. In the event the assigned individuals leave Subcontractor’s employ or are
reassigned to other programs, Subcontractor shall notify Baylor reasonably in advance
and the contract shall be terminated and all remaining funds will be returned to Baylor
within thirty (30) days. A final accounting shall accompany any returned funds. No
diversion or replacement shall be made by Subcontractor.
Key Personnel
W. Keith Hoots, M.D.
8. Assurances
Subcontractor agrees to exercise its best efforts to insure that all assurances required by
Federal and State Law are met. Such assurances and certifications required of
Subcontractor shall include but not necessarily be limited to:
a. Civil Rights and Equal Employment Opportunity
Subcontractor agrees that all employees, agents or other persons who are or who
shall be deigned to perform services or furnish goods or materials under or
pursuant to this Subcontract shall be selected without regard to race, color,
national origin, religion, sex, age or veteran or handicap status and in accordance
with applicable federal and state law governing equal employment and in
compliance with the policies of Subcontractor.
b. Student Unrest Provision
No part of the funds awarded under this Subcontract shall be used to provide the
salary of or any compensation whatever to any individual applying for admission,
attending, employed by, teaching at, or doing research at any institution or higher
education who has engaged in conduct on or after August 1, 1969, which involves
the use of (or the assistance to others in the use of) force or the threat of force of
the seizure of property under in the control of an institution of higher education,
to require or prevent the availability of certain curriculum, or to prevent the
faculty, administrative officials, or students in such institution from engaging in
their duties or pursuing their studies at such institution.
c. Protection of Human Subjects
The Subcontractor agrees that the rights and welfare of human subjects involved
in performance of this subcontract will be protected in accordance with
procedures specified in its current Institutional Assurance on file with the Office
of Protection from Research Risks, OD, NIH. The subcontractor further agrees to
provide certification at least annually that an appropriate institutional committee
has reviewed and approved the procedures which involve human subjects in
accordance with the applicable Institutional Assurance accepted by the Office for
Protection from Research Risks, OD, NIH. The Subcontractor shall bear full
responsibility for the performance of all work and services involving the use of
human subjects under this Subcontract in a proper manner and as safely as is
feasible. The parties hereto agree that the subcontractor retains the right to control
and direct the performance of all work under this Subcontract. No provision of
this Subcontract shall be deemed to constitute the Subcontractor, agent or
employee of the Subcontractor or any other person, organization, institution, or
group of any kind whatsoever, as the agent or employee of the U.S. Government.
The Subcontractor agrees that it has entered into this subcontract and will
discharge its obligations, duties, and undertakings and the work pursuant thereto,
whether requiring professional judgment or otherwise, as an independent
subcontractor without imputing liability on the part of the Government for the acts
of the Subcontractor or its employees.
d. Care Treatment of Laboratory Animals
To the extent warm-blooded animals are involved in the research work, the
Subcontractor warrants that it will comply with applicable portions of the Animal
Welfare Act (P.L. 89-544 as amended) and with the applicable federal laws,
regulations, and policy statements issued by the U.S. Department of Health and
Human Services now currently in effect.
e. Debarment, Suspension, Repayment of Federal Debt
Subcontractor certifies, by signing this document, that neither it nor its
principal(s) is presently debarred, suspended, proposed for debarment, declared
ineligible, or voluntarily excluded from participation in this transaction by any
federal department or agency. Subcontractor certifies, by signing this document,
that neither it nor its principal(s) is delinquent on the repayment of any federal
debt.
f. Certification Regarding Lobbying
The Subcontractor certifies, to the best of his or her knowledge and belief, that:
No Federal appropriated funds have been paid or will be paid, by or on behalf of
the undersigned, to any person for influencing or attempting to influence an
officer or employee of any agency, a Member of Congress, an officer or employee
of Congress, or an employee Member of Congress in connection with the
awarding of any Federal contract, the making of any Federal grant, the making of
any Federal loan, the entering into of any cooperative agreement, and the
extension, continuation, renewal, amendment, or modification of any Federal
contract, grant, loan or cooperative agreement. If any funds other than Federal
appropriated funds have been paid or will be paid to any person for influencing or
attempting to influence an officer or employee of any agency, a Member of
Congress, an officer or employee of Congress, or an employee of a Member of
Congress in connection with this Federal contract, grant, loan, or cooperative
agreement, the undersigned shall complete and submit Standard Form-LLL,
“Disclosure Form to Report Lobbying”, in accordance with its instructions.
g. Anti-Kick Back Act of 1986
Subcontractor certifies, by signing this document that to the best of their
knowledge they have not received any money, fee, commission, credit, gift,
gratuity, things or value, or compensation of any kind, provided directly or
indirectly, for the purpose of improperly obtaining or rewarding favorable
treatment in connection with the prime contract or in connection with this
subcontract relating to a prime contract.
h. Standards of Conduct
Subcontractor certifies, by signing this document, that subcontractor’s institution
has written policy guidelines on conflict of interest and the avoidance thereof. For
the requirement of a code of conduct applicable to procurements under PHS
grants and cooperative agreements, see the procurement standards prescribed by
45 CFR Part 74, Subpart P and 45 CFR Part 92.36. Subcontractor must give each
officer, employee, board member, and consultant who is working on the
subcontract a copy of the written policy guidelines on conflict of interest. These
rules of conduct need not be formally submitted to Baylor, however they must be
made available for inspection by representatives of Baylor or the Federal
Government.
i. Other Assurances
Subcontractor agrees to fulfill the requirements of any Assurances(s) as may be
required by DHHS for work undertaken during the performance of this
Subcontractor.
9. Patents, Licenses, and Inventions
a. Definitions
The term “Know-How” shall mean all patentable and unpatentable technical
information, trade secrets, devices, model things, know-how, methods,
documents, materials, and all other confidential information related to the
performance of work as described in “Exhibit A”. The term “Patent Rights” shall
mean any patentable devices, methods or procedures related to the performance of
work as described in “Exhibit A”, and all patents, reexaminations, reissues,
renewals, extensions, divisionals and continuations issued thereon and all foreign
counterparts thereof. The term “Licensed Product(s)” shall mean any product
which incorporates or utilizes the Know-How or the Patent Rights.
b. Disclosure
Subcontractor shall report to Baylor and the Federal Government any inventions,
first actually reduced to practice in the performance of this agreement which shall
be administered in accordance with Public Law 98- 620 and 37 CFR Part 401.
c. Patents and Know-How
Inventions and patents which result form this agreement shall be administered in
accordance with Public Law 98-620 and 37 CRF Part 401. The Subcontractor
represents that its policies require appropriate assignments of inventions, knowhow and improvements from all persons who perform any part of the work under
this agreement. Disposition of title to inventions, the filing of patent applications,
disposition of patent rights and licensing covering the manufacture, use and sale
of products and processes shall be governed by 37 CFR Part 401.
d. Grants of Licenses
Subcontractor hereby grants to Baylor and the Federal Government a nonexclusive, non-transferable, irrevocable license to any licenses product(s),
developed under the project research.
10. Limitation of Costs
It is recognized that the amount(s) funded for this Subcontract is based on anticipated or
estimated costs. However, it is agreed herein that Baylor’s obligation shall not exceed the
sum allotted for this Subcontract in paragraph 3. Neither Baylor nor DHHS shall be
obligated to reimburse Subcontractor for cost incurred in excess of the amount allotted
for the performance of this contract.
11. Program Income
Program income will be treated in accordance with PHS Grants Policy Statement, DHHS
Publication No. (OASH) 94-50,000 (Rev.) April 1, 1994. Subcontractor will report
Program Income to the Sponsor through Baylor at least annually and no later than 60
days after termination of this Subcontract.
12. Equipment Accountability and Disposition
For purposes of this subcontract, equipment is defined as those items costing $500 or
more and having a useful life of more than two years. Title to all equipment purchased on
this subcontract shall vest in subcontractor upon acquisition, subject to the provisions of
45 CFR 74.136. An inventory of all equipment must be maintained by subcontractor.
13. Reports & Records Inspection
Subcontractor agrees to furnish in a timely manner and appropriate format, such progress
reports, schedules, cost reports, and other information required by the project, for
incorporation by Baylor in meeting its reporting requirements to DHHS. Reports should
be filed with:
Wiliam T. Shearer, M.D.
Baylor College of Medicine
One Baylor Plaza
Houston, Texas 77030-3498
a. Accounting and Records
The accounting for the Subcontract funds will be in accordance with generally
accepted accounting principles consistently applied and in accordance with cost
principles of the U.S. Department of Health and Human Services. Subcontractor
shall maintain records to support identifiable charges to the project. Obligations,
commitments, encumbrances or expenditures should be made within the budget
period.
b. Audit Requirement
If Subcontractor is subject to the audit requirements of OMB Circulars A- 128 or
A-133, Subcontractor shall submit a copy of its most recent financial and
compliance audit report to the Director of Grants & Contracts, One Baylor Plaza,
Rm. MT-601, Houston, Texas 77030, prior to the execution of this subcontract. If
the Subcontractor is not subject to A-128 or A-133, the Subcontractor shall have
an audit of the program conducted and submitted to Baylor within 90 days of the
end of the period of performance as specified in this subcontract. This audit will
be conducted by an independent certified public accounting firm and shall be
conducted in accordance with generally accepted Governmental Audit Standards
as issued by the Comptroller General of the United States. Subcontractor certifies
that, in instances of noncompliance with Federal laws and regulations, appropriate
corrective action will be taken. Subcontractor agrees to notify Baylor of the
management decision issued by the responsible federal agency and of the
completion of the corrective action plan within six months of furnishing the audit
report to Baylor. The Subcontractor’s facilities, or such part thereof as may be
engaged in the performance of this Agreement, and any pertinent books,
documents, papers and records shall be subject at all reasonable times to
inspection and audit by representatives of Baylor or the Federal Government.
14. Additional Provisions
It is agreed that the PHS Grants Policy Statement, policies, etc., in existence at the time
of performance of this Subcontract are automatically incorporated and made a part of this
Subcontract.
15. Amendment and Modification
This agreement, or any portion hereof, may be amended or modified in writing at any
time as mutually agreed upon, or as required by DHHS.
16. Limitation of Liability
Subcontractor is and will at all times be acting as an independent contractor in the
performance of this work and not as an agent or joint venturer of Baylor. In so far as is
authorized under the constitution and laws of the State of Texas, Subcontractor shall
indemnify and hold Baylor harmless from liability resulting from Subcontractor acts or
omissions within the terms of this agreement; provided, however, Subcontractor shall not
hold Baylor harmless from any claims, demands, or causes of action arising in favor of
any person or entity, growing out of, incident to, or resulting directly or indirectly from
negligence (whether sole, join, concurrent or otherwise), or Baylor, its officers, agents or
representatives, or employees not subject to supervision or control. Baylor shall hold
Subcontractor harmless from liability resulting from Baylor’s acts or omissions within
the terms of this agreement; provided, however, Baylor shall not hold Subcontractor
harmless from any claims, demands, or causes of action arising in favor of any person or
entity, growing out, incident to, or resulting directly or indirectly from any negligence
(whether sole, joint, concurrent or otherwise), of the Subcontractor, its officers, agents or
representatives, or employees not subject to supervision or control.
17. Termination of Agreement
Either Baylor or Subcontractor may terminate this subcontract upon thirty (30) days
written notification to the other party. In the event of termination, Subcontractor will be
reimbursed for any non-cancelable obligations properly incurred prior to the date of
notice of termination.
18. Law
This subcontract shall be construed according to the laws of the State of Texas and any
and all disputes arising hereunder shall be resolved in the courts of the State of Texas;
provided, however, that any patent question or controversy shall be resolved in the courts
having jurisdiction over the patent or patents in question and in accordance with the laws
applicable to such patent or patents.
19. Federal Demonstration Project
Where subcontractor is a participant in the Federal Demonstration Project, this
subcontract is subject to the Federal Demonstration Project General Terms and
Conditions and any agency specific requirements. Baylor retains approval authority for
extension of time and the carryover of unobligated funds and foreign travel.
By:_____________________________________ Date:___________________________
Baylor College of Medicine
R.R. Rich, M.D.
Vice President and Dean for Research
By:_____________________________________ Date:___________________________
The University of Texas Health Science Center at Houston
Jim Darcy
Director of Accounting
Financial Resources
Read and understood:
_____________________________________
Dr. Keith Hoots
Principal Investigator
Date:_______________
EXHIBIT A WORKSCOPE
5 U01 AI27551-08
Dr. Hoots will be responsible for all activities of this subcontract including coordination
of all research activities at the various study sites to be used by the University of Texas.
Dr. Hoots will coordinate research and clinical care for all hemophilic and pediatric
AIDS patients enrolled at the University of Texas and will coordinate all clinical and
research activities. Dr. Marilyn Doyle will serve as clinical coordinator for the pediatric
patients enrolled at the University of Texas. She will oversee the day by day activities of
patient enrollment and management and will be the clinical coordinator for all hemophilic
patients enrolled and will oversee the day by day activities of patient management.
The protocol nurse will assist with enrollment of patients, coordination and supervision
of outpatient and inpatient care and close follow-up after the patients return home.
Additional responsibilities will include referral to appropriate consultants, patient and
family education, facilitating school attendance, promotion of other activities of daily
living and scheduling examination, laboratory tests and radiographs. The pediatric nurse
practitioner will assist with implementation of chemotherapy protocols, medications, and
growth development assessment. The social worker will assist families of all patients
enrolled by identifying community resources to meet their social and financial needs. She
also will provide supportive counseling in the areas of adjustment to diagnosis, treatment
regimen and long term prognosis. The development neuropsychologist will evaluate each
patient for growth and development and obtain complete psychosocial assessments on
each patient.
EXHIBIT B
BUDGET
5 U01 AI27551-08
The University of Texas Health Science Center at Houston
Personnel $60,909
Supplies $1,466
Travel $1,955
Other Expenses $4,888
Total Direct Costs $69,218
Indirect Costs $13,152
Total Costs $82,370